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Open, Classified

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

FDA Recall Z-1317-2023 · Posted 2023-04-01

Recalling FirmLimacorporate S.p.A
Recall StatusOpen, Classified
Product CodeMBF
Date Initiated2023-02-21
Product Quantity1

Reason for Recall

Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

Firm Action

On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to [email protected] 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to [email protected]

Root Cause

Process control

Distribution Pattern

US: MO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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